ADVANCED MAGNETICS MODIFIES PROGRAM FOR IV IRON REPLACEMENT THERAPY
Advanced Magnetics announced that after a recent meeting with the FDA to evaluate its Phase III development program for ferumoxytol in IV iron replacement therapy, the company plans to revise the program to include a new primary efficacy analysis suggested by the FDA.
The revised efficacy analysis is consistent with the analysis upon which a recent approval of another IV iron product was based. These modifications will result in additional patients being enrolled in the ferumoxytol chronic kidney disease efficacy studies and will involve the re-design of the hemodialysis protocol currently under way. Advanced Magnetics also plans to add additional patients to the large-scale safety study in order to provide a more robust safety database for the new drug application.